By Daniel S. Wittenberg and Tim Scalo[1] On June 16, 2016, the Food and Drug Administration (FDA) released a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions[2]. The non-binding draft guidance provides clarity to FDA staff and the medical device industry by setting out the benefit […]
On June 21, 2016, the Federal Aviation Administration (FAA) unveiled a landmark set of new rules for the commercial operation of small Unmanned Aircraft Systems (sUAS), more popularly known as drones. The new rules will take effect in late August 2016 and only apply to commercial uses for drones weighing less than 55 pounds. Designed […]
Product liability cases in Arizona continue to generate more defense verdicts than plaintiff’s verdicts, though there was a large award in 2016. Since 2012, Arizona juries have given twelve defense verdicts and three plaintiff’s verdicts. -Coulbourn v. Crane Company and The William Powell Company, United States District Court for the District of Arizona (2016). George […]
The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer Inc., for treatment of rheumatoid arthritis, inflammatory bowel diseases and other conditions. Inflectra is a biosimilar to Remicade which has been […]
The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine was incompatible with the Uniform Contribution Among Tortfeasors Act (“UCATA”). Although the Arizona Supreme Court specifically held that the doctrine applies to pharmaceutical […]
What will be the key issues for the Internet of Things in 2016? JD Supra Business Advisor asked me and other privacy and data security lawyers to comment. Securing these devices is at the top of the list. Here’s the full article. The Internet of Things is the universe of smart devices that talk to […]
Owners of many small unmanned aerial systems (“sUAS” or “drones”) and model airplanes will have to register them with the government. The Federal Aviation Administration announced the requirement in an interim final rule on December 14. The FAA touts the new regulation as providing “an alternative, streamlined and simple web-based aircraft registration process for sUAS…to […]
Two recent rulings illustrate the widely varying responses courts have taken in confronting an emerging national issue: how to measure damages for past medical expenses when the hospital’s treatment charges, before discounts and write-offs, dramatically exceed the sums actually paid for the health care provided. Although a seemingly simple question, courts around the country have […]
The amendments that changed Federal Rule of Civil Procedure 26 on December 1, 2015 re-define the scope of discovery and seek to rein in abusive over-discovery. Two revisions in particular demonstrate that these amendments narrow the framework of allowable discovery. First, the amendments delete from Rule 26(b)(1) the provision that discovery may seek relevant but […]
The Texas Supreme Court’s ruling in Nabors Well Services, Ltd. v. Romero, 456 S.W.3d 553 (Tex. 2015) has re-opened the national debate about whether courts should admit evidence of seat belt non-usage in lawsuits arising from motor vehicle crashes. The Romero decision reversed the course that Texas courts had followed for more than forty years […]
